# K141434: Saturn 5 Laser

- Pathway: 510(k) (Traditional)
- Applicant: Research Instruments, Ltd.
- Decided: Feb 18, 2015 after 264 days
- Product code: MRX (System, Assisted Reproduction Laser)
- Device class: 2
- Regulation: 21 CFR 884.6200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K050768 (2005). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083208: Saturn Active Laser System, Research Instruments, Ltd. (2009) Summary page 4.
- K060764: Saturn 3 Laser System, Research Instruments, Ltd. (2007) Summary page 4.

## Most influential descendants
- K253333: Assisted Reproduction Laser System (Model ILS-400M) (2026), 0 descendants of its own
- K202241: LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) (2021), 0 descendants of its own
- K192008: LaserShot M, NaviLase (2020), 0 descendants of its own

## Indications for use
For use in assisted reproduction procedures to ablate or thin the zona pellucida of an oocyte or embryo to facilitate assisted hatching or recovery of cells for pre-implantation genetic diagnosis (blastomeres). The device can also be used on blastocyst stage embryos for biopsy of trophectoderm cells for pre-implantation diagnosis procedures, and blastocyst collapse prior to vitrification procedures.

Source page: https://510kreport.com/device/K141434
Methodology: https://510kreport.com/methodology